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The Evolving Role of Real-World Data in Specialty Care

November 6, 2015

Over the past several years, Cardinal Health Specialty Solutions has published a series of studies examining the role of real-world data in understanding cancer and immunology, and how such research can be used to improve the quality and value of care. This fall, the team has added to its compendium of research with 10 new studies published at the annual meetings of the American Society of Hematology (ASH), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and the American College of Rheumatology (ACR). Here, Dr. Bruce Feinberg talks about the latest round of research and how real-world evidence is providing new insights on a variety of healthcare issues ranging from patterns of care, cost of care, and predictors of acute care interventions, to treatment persistency and decisions about switching insurance.

Q. Why expand upon Cardinal Health’s existing body of work in Health Economics and Outcomes Research (HEOR)?

A. It is now universally recognized that traditional clinical research will not provide sufficient data to address the needs of value-based care modeling. Real world evidence research will not only be needed, but likely will be foundational to this task. Understanding patterns of care, cost of care, resource utilization, and the factors that drive them has been the focus of Cardinal Health’s HEOR research since 2012. This year’s work continues to expand the depth and breadth of our analysis.

Q. The studies published at ASH focus on identifying the factors that can predict whether patients with chronic lymphocytic leukemia will need to go to the ER during their chemotherapy regimen. Can you talk about the results of these studies and why they are important?

A. Our prior work, as well as other studies, suggests that patients undergoing active cancer treatment frequently need acute care at an emergency room. This emergency care not only adds significant cost, but can impact quality and patient experience – particularly if those patients are admitted to the hospital, which occurs for two-thirds of patients. Our new study identifies some of the key predictors of ER visits including increased age, duration of chemotherapy, number of adverse events and use of supportive care. Our hope is that if the predictors of ER visits can be established, we can uncover opportunities to intervene sooner with services to prevent the need for ER evaluations and related hospitalizations, which might ultimately lower cost and improve outcomes.

HEOR publications

Q. You’ve said that one of the benefits of real-world evidence is that it can help providers deliver better, more effective care to patients. One example is the study published at ISPOR, which found that breast cancer patients were kept on therapy longer when their therapy doses were modified to manage toxicity. What should healthcare providers take away from this study?

A. The development of precision medicines is an exciting advancement in the treatment of complex diseases such as cancer. But it also places a huge burden on healthcare providers as they struggle to maintain the knowledge base required to treat patients with the wealth of available therapeutics. Oncologists are migrating from an era in which ten drugs were used to treat one hundred diseases to an era where one hundred drugs are needed to treat ten diseases. The implications for patients are significant if treatments are not optimized. In this study, we found that when providers adjusted doses of chemotherapy to manage toxicity, patients stayed on therapy longer – and we know that persistency of therapy contributes to better outcomes. As the industry focuses on improving the quality of care, it will be critical for providers to receive the education they need to understand how to optimize precision therapies.

Q. Another notable study published at ISPOR found that breast cancer patients tended to stay on their insurance plans longer than patients who did not have cancer. What implications do these findings have for payers and patients?

A. Our study found that breast cancer patients switched their healthcare insurance plans at a statistically lower rate than non-cancer patients (22.7% vs. 26%). This is consistent with other studies that show that patients with chronic conditions are less likely to switch insurance plans. The results are particularly significant as oncologists increasingly treat patients with immuno-oncology treatments that deliver more durable remissions at a higher initial cost but lower global cost. Payers benefit from the long term savings associated with remission if their members maintain their coverage after initial diagnosis and treatment. As patients become more engaged in driving their own health and coverage decisions, and payers continue to work to define the global cost of care, studies like this will help all stakeholders to make more informed decisions.

Q. As you attend medical meetings and speak with your fellow healthcare providers, do you sense that opinions about real-world evidence are changing? If so, how?

A. We have seen a substantial shift in thinking about real-world evidence over the past year. Past ASCO president, Dr. Peter Yu, made the case for greater use of real-world data, stating that traditional clinical trials do not fully represent the entire population of cancer patients. Subsequently, ASCO announced the creation of the TAPUR study, a first-of-its-kind research study that will offer patients with advanced cancer access to molecularly-targeted cancer drugs and collect real-world data on outcomes to help learn the best uses of these drugs outside of indications approved by the FDA. In addition, organizations like ASCO and the National Comprehensive Cancer Network (NCCN) have recently introduced value calculators to assess the value provided by different cancer drugs, which have reinforced the limitations of clinical trials in meeting the demands of medical decision making today. I think practicing physicians are not only receptive, but eager to learn from this new and evolving data source.